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We have the following open positions:

Scientists at various levels (Job code: SCI033)

The candidates must have a Ph.D. degree in biology or chemistry. Postdoctoral training in relevant fields is strongly recommended. We expect the candidates to have demonstrated independent research capability and excellent productivity with strong publication record. Drug-development experience is NOT required.

The successful candidates will be compensated competitively according to their qualifications. The compensation package includes a salary starting from ,000 for entry-level positions and 0,000 for the senior position (from scientists to principle scientist), plus bonus and generous stock option plans. The Beijing-based positions will be compensated with equivalent RMB. We have immediate openings of five entry-level positions and one senior position. But we will never turn down a talented scientist.

The scientists will work in Beijing- and/or US-based R&D laboratories, which are joined by many independent and collaborating labs, not dissimilar to an integrated graduate program in academics. Each lab, led by a principle investigator (you could be one of them), carries on one or more drug development programs, initiated by the PIs or assigned by the management. In addition, the PIs are allowed to spend up to 20% of time and effort to engage in their own research interest. Publication is highly encouraged.

Managing DirectorMedical / Clinical Operation expertise Job code: MED009

This is a full time position. The incumbent reports to board of directors of Gan&Lee USA and leads the clinical development of the diabetes disease area. The successful candidate will function as a scientific and medical resource for the Medical Affairs department at Gan & Lee Pharmaceuticals, and as a medical monitor for ongoing clinical trials. 

Responsibilities:

  • Lead the development of global clinical study strategies for the assigned projects, including budget development 
  • Develop clinical protocols and amendments, investigator brochures
  • Identify and manage proper CRO companies
  • Conduct literature reviews and prepare summaries to support clinical development programs 
  • Lead medical affair team to provide appropriate medical monitoring for ongoing clinical studies and be responsible for oversight of adverse event reporting, safety monitoring, adherence to protocols
  • Evaluate safety, pharmacology and efficacy data from ongoing and completed studies and generate clinical study reports 
  • Work with Regulatory and other partners/stakeholders in the completion and submission of various regulatory applications, such as IND /CTA, NDA / (a)BLA / MA, etc.; plays a central role in developing and review drug’s package insert
  • Provide appropriate guidance or training to improve working knowledge and productivity of the medical affairs team
  • Manage regular operation and administration of the US company
  • Seek potential partners for future business development and marketing

We are looking for someone who:

  • Is a self-starter, spirit of entrepreneurship and willing to accept challenges and be flexible to take upon broad responsibilities in a fast-growing, small company environment
  • Is a team player, works well in a team environment both as a leader and a key contributor
  • Has a collaborative style with internal company leadership, external development partners (e.g. CRO) and investigators/medical professionals 

Requirements:

  • MD or MD/PhD, 4-5 years of industrial working experience, preferably in metabolism drug development, preferably has business education background or experience
  • Solid knowledge of clinical research development process
  • Strong working knowledge of relevant U.S. and EU regulations and clinical quality assurance guidelines
  • Excellent oral and written communication skills.

Manager, Regulatory Affairs (Job code: REG012)

Working closely with Associate Director of Regulatory Affairs, the incumbent will be responsible for outlining the regulatory strategy, coordinating activities related to regulatory interactions, such as global regulatory filing, meetings, etc.

Responsibilities:

  • With some guidance, contribute to the development and implementation of global regulatory strategies for assigned projects
  • Act as a regulatory liaison to interact with the external partners, and internal-functional departments; participate in or lead project teams
  • Be responsible for managing the preparation, compilation, and submission of regulatory applications, such as meeting packages, INDs / CTAs, BLAs / MAAs, and their supplemental filings
  • Collaborate with CRO’s and cross-functional partners throughout the drug development process to ensure compliance with regulatory requirements
  • Stay abreast of global competitive landscape, regulatory environment, regulations and guidance

We are looking for someone who:

  • Is a self-starter, and able to work well independently
  • Willing to accept challenges and be flexible to take upon broad responsibilities in a fast-growing, small company environment
  • Is a team player, works well in a team environment either as a leader or a key contributor

Requirements:

  • Minimum Bachelor’s degree in a scientific or related disciplines, 5+ years of pharmaceutical industrial experience, minimum 3 years in Regulatory Affairs.
  • Working knowledge of current regulations and guidances
  • Excellent organizational, oral and written communication skills. Fluent in Chinese preferred, but not required
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Associate Director, Regulatory Affairs(Job code: REG015)

Reporting to Executive Director of Regulatory Affairs, the incumbent will be responsible for outlining the regulatory strategy, coordinate activities related to regulatory interactions, such as global regulatory filing, meetings, etc.

Responsibilities:

  • Actively contribute to the development and implementation of global regulatory strategies for assigned projects
  • Serve as the primary point of contact with health authorities, especially FDA and EMA
  • Act as a regulatory liaison to interact with the external partners, and internal-functional departments; participate in or lead project teams
  • Be responsible for managing the preparation, compilation, and submission of regulatory applications, such as INDs / CTAs, BLAs / MAAs, and their supplemental filings
  • Collaborate with CRO’s and cross-functional partners throughout the drug development process to ensure compliance with regulatory requirements
  • Stay abreast of global competitive landscape, regulatory environment, regulations and guidance
  • May supervise one or more junior staff
  • Participate in Business Development efforts, as assigned

We are looking for someone who:

  • Is a self-starter, and able to work well independently
  • Willing to accept challenges and be flexible to take upon broad responsibilities in a fast-growing, small company environment
  • Is a team player, works well in a team environment both as a leader and a key contributor

Requirements:

  • Minimum Bachelor’s degree in a scientific or related disciplines, 7+ years of pharmaceutical industrial experience, minimum 5 years in Regulatory Affairs. Global experience desirable
  • Working knowledge of global regulations and guidances as they relate to the global regulatory strategy
  • Working experience of eCTD submission
  • Excellent organizational, oral and written communication skills. Fluent in Chinese preferred, but not required

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Interested candidates can submit their applications electronically to hrrd@ganlee.com.